Printed on: Fri Jan 05 2024, 10:23:27 PM(EST) Status: Currently Official on 06-Jan-2024 DocId: GUID-EF4F7837-CC10-42C6-9E2F-25827B72F304_1_en-US
Printed by: USP NF Official Date: Official Prior to 2013 Document Type: USP @2024 USPC
Do Not Distribute DOI Ref: v2zom DOI: https://doi.org/10.31003/USPNF_M13830_01_01
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Detector: Flame ionization
Aromatic Castor Oil Column: 1.8-m × 4-mm column packed with 4% liquid
DEFINITION phase G25 on support S1
Aromatic Castor Oil is Castor Oil containing suitable flavoring Column conditioning: Flush with helium for 2–5 min,
agents. It contains NLT 95.0% of castor oil. then heat without further flushing at 250° for NLT 30 min,
then cool to room temperature, and finally heat while
ASSAY helium is flowing through it at 250° for NLT 60 min.
• PROCEDURE Temperature
Internal standard solution: 12 mg/mL of di(2-ethylhexyl) Column: 245°
phthalate in chloroform Injector: 300°
Standard solution: Transfer 100 mg of Castor Oil to a Detector: 300°
100-mL boiling flask equipped with a suitable reflux Flow rate: Adjust to obtain a peak due to castor oil 5.5 min
condenser connected by a ground-glass joint. Add 30 mL after introduction of the specimen and an internal
of a mixture of 300 mL of methanol and 3.7 mL of sulfuric standard peak 8 min after introduction of the specimen.
acid, reflux in a water bath maintained at 75°–80° for 2.5 h, Carrier gas: Helium
cool, and rinse down the condenser with 10 mL of water. Injection size: 5 µL
Transfer the contents of the flask to a 125-mL separator with Analysis
the aid of 10 mL of water. Rinse the condenser and the flask Samples: Standard solution and Sample solution
with 25 mL of solvent hexane, and transfer to the separator. Measure the heights of the peaks due to castor oil and the
Shake the separator for 2 min, and draw off the aqueous Internal standard solution.
layer into a second 125-mL separator. Add 20 mL of solvent Calculate the percentage of castor oil in the portion of
hexane to the second separator, shake for 2 min, discard Aromatic Castor Oil taken:
al
the aqueous layer, and transfer the solvent hexane layer to
the first separator with the aid of 10 mL of solvent hexane. Result = (RU/RS) × (Ws/WU) × 100
Wash the combined extracts with three 5-mL portions of
water, discarding the washings, and transfer the washed RU = ratio of the heights of the peaks due to castor oil
extract to a 125-mL conical flask, through a funnel and the internal standard, Sample solution
containing anhydrous sodium sulfate, with the aid of 25 mL RS = ratio of the heights of the peaks due to castor oil
of solvent hexane. Place the flask in a hot water bath, and
evaporate with the aid of a current of air to dryness. To the
residue add 10.0 mL of Internal standard solution, and mix
ci WS
and the internal standard, Standard solution
= weight of Castor Oil taken to prepare the
Standard solution (mg)
until solution is complete. WU = nominal weight of castor oil in the sample of
Sample solution: Transfer an amount of Aromatic Castor Aromatic Castor Oil taken to prepare the Sample
ffi
Oil, well-shaken and nominally equivalent to 100 mg of solution (mg)
castor oil, to a long-neck, round-bottom 100-mL boiling
flask equipped with a suitable reflux condenser connected Acceptance criteria: NLT 95.0%
by a ground-glass joint. Proceed as directed for the OTHER COMPONENTS
Standard solution, beginning with “Add 30 mL of a mixture • ALCOHOL DETERMINATION, Method I á611ñ: NMT 4.0%
of 300 mL of methanol and 3.7 mL of sulfuric acid…”. of C2H5OH
O
Chromatographic system
(See Chromatography á621ñ, System Suitability.) ADDITIONAL REQUIREMENTS
Mode: GC • PACKAGING AND STORAGE: Preserve in tight containers.
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